Scope question

#1
Hi all
My Company is ISO9001 approved for sale, manufacture etc for Product type A and only make Product type A, they now want to import / distribute a Product type B which is completely different from anything we do and not covered by our Current ISO 9001 scope - what is the best way to proceed as this is a new one on me? we would jusf be a distributor for product type B.
Hope someone can advise?
Thanks in advance.
 
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John C. Abnet

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#2
Good day @3pinplug ;
You will want to perform a gap analysis to identify and address any aspects that your organization may not be currently addressing...specific to the new product "B" distribution activity.
I recommend you contact your registrar to get specific "path forward" direction. Most registrars have a "scope expansion" that will cause them to perform an audit specific to/limited to the additional activity.

Hope this helps.
Be well.
 

Cari Spears

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#4
Welcome to the cove, 3pinplug!

Do your product B customers require your organization to be ISO registered? Are they the same customers that currently buy your product A?
 

Ed Panek

QA RA Small Med Dev Company
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Super Moderator
#6
This is the key question. From a high-level corporate strategy path is this a one-off or not? Does it make sense or add value to add the 9001 label to the device? If not, its outside the scope of your QMS.
 
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